SUMMARY OF POSITION The Associate, Regulatory Labeling prepares, reviews and submits to his/her manager high-quality regulatory labeling submissions intended for the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws. Submissions will include ANDAs, amendments, supplements, Annual Reports and advertising and promotion campaigns. This position researches and, under the direction of the Legal Team, prepares appropriate labeling carve-outs based on submission strategies. He/she provides guidance to teams and peers on labeling guidelines and works to solve increasingly complex labeling projects/problems. This individual is responsible for preparation of labeling in meeting regulatory submission timelines. He/she prepares, reviews and submits Structured Product Labeling to FDA and is responsible for Drug listing activities.
ORGANIZATION STRUCTURE The Associate, Regulatory Labeling reports into the Director Labeling and is based in Pine Brook, New Jersey.
RESPONSIBILITIES Primary responsibilities of this role include the following:
QUALIFICATIONS Minimum of a Bachelor’s Degree in a scientific discipline or English major. • Minimum of 5 years in the pharmaceutical industry with 2-3 of those years in regulatory affairs labeling.
Job-Specific Competencies/Skills: • Excellent verbal and written communication skills. • Highly motivated, results driven with unyielding predisposition to detail, accuracy and clarity. • Demonstrates in-depth knowledge and understanding of FDA guidelines with proven ability to successfully apply these to work output. • Performs duties with the highest ethical standards, delivering only high-quality, compliant submissions to FDA. • Strong critical and logical thinker with ability to analyze problems and recommend solutions. • Effectively communicates regulatory requirements and strategies as they affect regulatory submissions to internal and external partners. • Demonstrates a sound ability to make appropriate decisions on regulatory labeling activities and work outputs • Effectively prioritizes competing tasks in a fast-paced and dynamic environment. • Ad Promo experience preferred. • Knowledge of print process or graphics a plus.
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